PROCEDURES FOR SCIENTIFIC REVIEW AND SCIENTIFIC MONITORING: Cancer Protocol Committee and the Cancer Sciences Subcommittee Scientific Review Criteria The Cancer Protocol Committee is charged with the scientific peer review of all cancer-related therapeutic (agent or device) research protocols. All cancer-related protocols, regardless of sponsorship, must be approved by the CPC before final IRB approval will be granted. The Committee's evaluation of scientific merit of the proposed research includes consideration of the following areas Rationale of the proposed research and supporting preliminary data Scientific design Appropriateness of the eligibility criteria (including justification for inclusion of a pediatric population if applicable) Feasibility for completion (including potential accrual and competing studies) Risks and benefits as they relate to the scientific merit Biostatistical rigor The primary review emphasis is on the scientific merit of the proposed research. In granting approval of a therapeutic trial and access to the proposed subject population, the committee bases its decision on the level of scientific merit, Center priorities, and the feasibility for completion of the trial within a scientifically relevant period of time. The Committee also serves in an advisory capacity to the ORB on issues of research risk and informed consent. The adequacy of each of the areas enumerated above is judged in accordance with specific criteria which are enumerated on protocol review forms. The intent is to enhance the quality of clinical research by providing constructive criticism to the investigator proposing the research. In pursuit of this goal, guidelines for the writing of oncology protocols have been established, modeled after those of the NCI's, and are available to investigators ("The Essential Elements of an Oncology Protocol"). The process for the scientific monitoring of institutional protocols is done by the CPC in collaboration with the Scientific Monitoring Subcommittee. This is addressed below in the section entitled "Scientific Monitoring."